A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-01-31

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetics of golimumab in Chinese male participants.

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Detailed Description

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This is a randomized (study medication assigned by chance), open-label (both the physician and subject know the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), of golimumab (Simponi). The study population will consist of 24 healthy male participants in China. Subjects will receive a single dose of either 50 mg or 100 mg golimumab. Subjects will be in the study for up to 14 weeks. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (eg, blood pressure), and the occurrence and severity of adverse events. A single dose of 50 mg or 100 mg golimumab as a subcutaneous injection.

Conditions

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Healthy Adult Chinese Males

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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001

Golimumab Single dose of 50 mg subcutaneously

Group Type EXPERIMENTAL

Golimumab

Intervention Type DRUG

Single dose of 50 mg subcutaneously

002

Golimumab Single dose of 100 mg subcutaneously

Group Type EXPERIMENTAL

Golimumab

Intervention Type DRUG

Single dose of 100 mg subcutaneously

Interventions

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Golimumab

Single dose of 100 mg subcutaneously

Intervention Type DRUG

Golimumab

Single dose of 50 mg subcutaneously

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have no clinically relevant abnormalities
* non-smoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study.

Exclusion Criteria

* Have or had a history of clinically significant, severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
* Have any underlying physical or psychological medical condition
* Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes